Weekly Paclitaxel-carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 11
- 主要终点
- Overall Response Rate
研究概览
简要总结
This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population
详细描述
Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic breast adenocarcinoma
- •No HER2 overexpression or gene amplification
- •Absent or low ER or PR expression
- •No previous therapy for metastatic breast cancer is allowed
- •Age 18-75 years
- •Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
- •Performance status (WHO) 0-2
- •Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
- •adequate renal function (serum creatinine <1.5 times the upper normal limit)
- •bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
- •No radiation of measurable disease (except brain metastases)
- •No progressive brain metastases according to clinical or radiological criteria
- •No brain metastases without prior radiation therapy
- •Written informed consent
排除标准
- •Active infection
- •History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •History of stroke
- •Anticoagulation therapy (except of low dose aspirin <325mg)
- •Other invasive malignancy except nonmelanoma skin cancer
- •Psychiatric illness or social situation that would preclude study compliance
- •Pregnant or lactating women
研究组 & 干预措施
1
Paclitaxel/Carboplatin/Bevacizumab
干预措施: Carboplatin (Drug)
1
Paclitaxel/Carboplatin/Bevacizumab
干预措施: Bevacizumab (Drug)
1
Paclitaxel/Carboplatin/Bevacizumab
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
次要结局
- Toxicity profile(Toxicity assessment of each chemotherapy cycle)
- Overall Survival(1 year)
- Time to Tumor Progression(1-year)
研究者
VASSILIKI SXOINA
Prof. D. Mavroudis
Hellenic Oncology Research Group